Device for occlusion of an oviduct

ABSTRACT

An occluding member, for being lodged in an oviduct where it narrows, e.g. at the junction between the ampulla and the isthmus, includes a tapered base portion and a narrowed forward portion. A suture attached to the occluding member is passed through an opening in the wall of the oviduct and is wrapped about the oviduct to occlude its walls against the forward portion of the occluding member. For inserting the occluding member, a separable rod passes the member through the inlet of the oviduct until it is lodged. Over the forward portion of the occluding member is temporarily positioned a suture guide, which holds the suture forward of the occluding member forward portion during positioning the occluding member and forms the opening in the wall of the oviduct. After the suture is drawn out of the oviduct through the opening in its wall, the suture guide is removed through the same opening in the oviduct wall.

United States Patent [451 Aug. 1, 1972 Cimber [54] DEVICE FOR OCCLUSIONOF AN OVIDUCT [72] Inventor: Hugo S. Cimber, 22 Seven Gables Rd., StatenIsland, N.Y. 10304 [22 Filed: May 11,1970

[211 App]. No.: 35,952

[52] U.S. Cl. ..l28/l R, 128/130, 128/341 [51] Int. Cl. ..A6lb 19/00[58] Field ofSearch ..l28/1 R, 127, 130, 131, 341, 128/343, 303

[56] References Cited UNITED STATES PATENTS 3,589,355 6/1971 Lee ..l28/lR 3,182,662 5/1965 Shirodkar ..128/303 3,042,030 7/1962 Read ..l28/l273,042,021 7/1962 Read ..l28/l R 3,422,813 l/l969 Braley et a1; ..128/1 RPrimary Examiner-Dalton L. Truluck Attorney-Ostrolenk, Faber, GerbSofi'en [57] ABSTRACT An occluding member, for being lodged in anoviduct where it narrows, e.g. at the junction between the am pulla andthe isthmus, includes a tapered base portion and a narrowed forwardportion. A suture attached to the occluding member is passed through anopening in the wall of the oviduct and is wrapped about the oviduct toocclude its walls against the forward portion of the occluding member.For inserting the occluding member, a separable rod passes the memberthrough the inlet of the oviduct until it is lodged. Over the forwardportion of the occluding member is temporarily positioned a sutureguide, which holds the suture forward of the occluding member forwardportion during positioning the occluding member and forms the opening inthe wall of the oviduct. After the suture is drawn out of the oviductthrough the opening in its wall, the suture guide is removed through thesame opening in the oviduct wall.

19 Claims, 8' Drawing Figures inf DEVICE FOR OCCLUSION OF AN OVIDUCT Thepresent invention relates to temporary sterilization of a female, andmore particularly to a device for occluding an oviduct and to a methodof installation of a device for occluding an oviduct. While manymechanical devices are known for temporary sterilization of a female,including intra-uterine contraceptive devices, most of these devices arenot held in the body of the female and may fall out without herknowledge. Furthermore, devices placed within the uterus may damage itssensitive walls or cause discomfort.

Another common technique for female contraception is to occlude or tieoff the Fallopian Tubes or oviducts to prevent ova and sperm frompassing therethrough. However, when an oviduct is occluded, its interiorsurfaces may adhere to each other, and the oviduct may be permanentlyand irrevocably sealed.

The present invention provides a mechanical means for temporarilysterilizing a female, which means cannot shift out of place without thefemales knowledge. Furthermore, the device does not contact the uterus.

The temporary sterilization device comprises an occluding member to belocated in the oviduct for blocking the passage of ova and sperm. Theoccluding member is so shaped as to be able to be lodged in a fixedposition within the oviduct and is provided with a securing means, likea suture, which secures the interior walls of the oviduct against theoccluding member, but not against each other, thereby preventingundesired irreversible oviduct wall adhesion.

The invention also comprises a novel method of inserting an occludingmember in the oviduct. The occluding member is positioned on aninsertion device. When the females abdominal cavity has been surgicallyopened, e.g. after a Caesarian birth, the entire length of the oviductis exposed to the surgeon. The insertion element is passed through theentrance of the oviduct, and the occluding member is moved through therelatively wide ampulla of the oviduct toward the narrower and moremuscular isthmus of the oviduct. The occluding member is shaped so as tolodge in the oviduct where it narrows. It is intended that the occludingmember usually lodge at the junction between the ampulla and theisthmus.

Secured to the occluding member is an occluding member securing means,e.g. a surgical suture, which is passed through an opening that has beenformed by the surgeon in the wall of the oviduct. The securing means isthen manipulated to occlude the walls of the oviduct about the forwardportion of the occluding member.

A guide means for the occluding member securing means may be removablymounted on the occluding member, e.g. by being positioned over thenarrowed forward portion of the occluding member. The securing means isheld forward of the occluding member by the guide means. The abovedescribed opening through the wall of the oviduct is made at the forwardposition where the guide means holds the occluding member securingmeans. The forward end of the guide means is sufiiciently sharp to bemanipulated to punch the opening through the wall of the oviduct. First,the securing means, and then the guide means therefor, are pulledthrough the opening in the wall of the oviduct. The securing means thentightens the walls of the oviduct, as noted above. With the securingmeans having been carried forward by the guide means therefor, the actof tightening the securing means about the occluding member draws theoccluding member further into the oviduct and thereby ensures that theoccluding member will be securely lodged in position.

After the occluding member has been moved into and lodged in position inthe tube, the insertion element may be removed by being drawn outthrough the entrance to the oviduct.

For later removal of the occluding member, it is necessary to surgicallyopen the females abdominal cavity, to cut the securing means, which isholding the occluding member in position, and to then remove theoccluding member by squeezing the walls of the oviduct against theoccluding member to force it out through the oviduct until it appears atthe open end of the oviduct.

Accordingly, it is a primary object of the present invention to providean efiective means for temporarily sterilizing a female.

It is another object of the present invention to provide such a device,which minimizes damage and discomfort to the user.

It is a further object of the present invention to provide such amechanical device, which will not accidentally fall out of place.

It is a further object of the present invention to provide a means foroccluding an oviduct without causing permanent blockage thereof.

It is a further object of the present invention to provide a method ofoccluding an oviduct.

These and other objects of the present invention will become apparentfrom the following description of the accompanying drawings, in which:

FIG. 1 is a schematic view of a portion of the female reproductivesystem, illustrating the invention in conjunction therewith;

FIG. 2 is an enlarged view of a portion of FIG. 1;

FIG. 3 is a perspective view of an occluding member in accordance withthe invention;

FIG. 4 isa further enlargement of a portion of FIG. 2;

FIGS. 5-7 show three stages in the emplacement of an occluding member;and

FIG. 8 is a view of a secured occluding member in the direction ofarrows 8 of FIG. 7.

Turning to the drawings, the relevant portions of the femalereproductive system are schematically illustrated in FIGS. 1 and 2.Uterus 10 has Fallopian Tube or oviduct 12 leading into it. As is wellknown, an ovum (not shown). passes from the ovary (not shown) into theabdominal cavity (not shown) where it is sucked into the inlet,interstitial or intramural portion 14 of oviduct 12. From there, itpasses through ampulla 16 and isthmus 18 and out the infundibulum 20into uterus l0. Fertilization of an ovum will occur during its passagethrough oviduct 12. In order to prevent fertilization of the ovum, it isnecessary to prevent sperm from travelling through the oviduct to meetan ovum and to prevent the ovum from travelling through the oviduct tomeet sperm.

The present invention provides a novel occluding member 24 (FIG. 3) foroccluding oviduct 12 so as to block the passage of both ova and sperm.Occluding member 24 is intended to be lodged and permanently held withinthe oviduct 24. Accordingly, it is comprised of a biologically inertmaterial, such as a plastic materia1, like polytetrafluoroethylene,which is distributed under the trademark TEFLON. Alternatively, thematerial might comprise a filled rubber material, based upontrifluoropropylmethylsiloxane units, a proprietary product marketedunder the trademark SILASTIC by Dow-Corning Company, U.S.A. Theoccluding member must also be sufficiently rigid so that the oviductwalls can be occluded against it, as described below.

Member 24 has a substantially circular cross-section along its entirelength and includes a base portion 26, which gradually inwardly tapersat neck 28 to merge at 30 into a thin, elongated forward portion 32. Thewidth of base portion 26 is such that member 24 will lodge in thepathway through oviduct 12. A convenient location for such lodging isthe junction 34 between ampulla 16 and isthmus 18, where the oviductnaturally narrows.

Secured to occluding member 24, back from its forward end 28, is asecuring means 40 for securing member 24 within the oviduct and for alsooccluding the walls of the oviduct against the occluding member, so asto block the oviduct while preventing adhesion of its interior walls.The securing means is back from forward end 38 so that when the means istightened, as described below, this will more securely lodge member 24in position. Securing means 40 may comprise a biologically inertconventional surgical suture which is used, as described below, tosecurely tie the walls of the oviduct against the occluding member. Thesuture may be embedded in, wrapped about a groove around or merely tiedsecurely to the occluding member.

For inserting occluding member 24, the abdomen of the female must beconventionally surgically opened. An insertion element, such aselongated rod 44 (FIGS. 1, 2, 4, has occluding member 24 mounted on it.Most simply, occluding member 24 has a depression 46 (FIG. 3) in itsbase, which depression is so dimensioned as to frictionally receive andhold occluding member 24 on the end of rod 44. Rod 44 is semi-rigid.Occluding member 24 is passed through oviduct inlet 14 and istransmitted by rod 44 to its lodgement position (FIG. 2). Thesemi-rigid, straight rod temporarily straightens the curved oviduct,while rod 44 is within it. When member 24 has been moved to itslodgement position, rod 44 is separated from member 24 and is withdrawnthrough the entrance to the oviduct. (See FIG. 7). The removal may beimmediately after insertion of member 24, but as illustrated insequential drawings FIGS. 5-7, it is preferred that removal of rod 40 bedeferred until after member 24 has been secured. The oviduct thenreassumes its normally curved orientation.

For securing occluding member 24 within oviduct l2, suture 40 is passedthrough an opening 48 that has been cut in the wall of the isthmus in amanner described below. The suture is then pulled tight and wrappedabout the exterior of the oviduct, as shown in FIGS. 7 and 8, andsqueezes the interior walls of the oviduct securely about forwardportion 32 of occluding member 24.

It is necessary that suture 40 be available to be grasped by the surgeonemplacing occluding member 24 after the occluding member has been lodgedin the oviduct. Opening 48 through which suture 40 is passed ispreferably slightly forward of the lodgement location of occludingmember 24, whereby when suture 40 is pulled, occluding member 24 isdrawn securely into junction 34 of oviduct l2 and blocks the passage. Tohold suture 40 forward of occluding member 24, guide means 52,comprising a hollow tube through which suture 40 is passed, has itshollow opening 53 fitted over forward portion 32 of occluding member 24and seats upon tapering portion 28 of member 24. The suture extends outof and is held by the open narrowed forward end 54 of guide means 52.Forward end 54 is suffi ciently rigid and sharpened as to be able topunch through the thin, relatively soft wall of the isthmus. End 54cannot be so sharp, however, that it will accidentally cut through thewall at a location where this is not desired.

The procedure for effecting temporary sterilization includes thepreviously described steps of opening the abdominal cavity to expose theoviduct, mounting occluding member 24 on insertion rod 44, passingsuture 40 through guide means 52, mounting the guide means on member 24and moving member 24 into the oviduct.

Once occluding member 24 has been lodged in position at junction 34,opening 48 is formed in the wall of the oviduct. Either or both of theoviduct and guide means 52 within the oviduct is grasped andmanipulated, by manipulation of rod 44 or twisting of oviduct 12, untilguide means forward end 54 punches opening 48. (See FIG. 5)

Suture 40, which has been held forward by guide means 52, and forwardend 54 of guide means 52 are drawn out of oviduct 12 through opening 48.(See FIG. 6). Guide means 52 is then shifted off forward portion 32 ofoccluding member 24, is drawn out of opening 48 and is then slipped offthe suture. The suture is then wrapped about the oviduct and tied intoposition, as shown in FIGS. 7 and 8.

At some time after occluding member 24 has been lodged in position andsuture 40 has been drawn through opening 48 and preferably before thesuture is wrapped about the oviduct, insertion rod 44 is released frommember 24 and removed from the oviduct.

When the walls of the oviduct are securely tightened about the forwardportion of the occluding member, the oviduct is blocked against thepassage of ova and sperm.

Since occluding member 24 is permanently lodged in the oviduct, toreestablish fertility, it is necessary to remove occluding member 24.The abdominal cavity of the female must be opened. Securing means 40 isreleased. Occluding member 24 is then removed by squeezing the walls ofthe oviduct against the tapered neck 28 of member 24 which shifts member24 toward and eventually out of the open entrance into the oviduct, thesame insertion rod 44 being passed through the oviduct and engaging theoccluding member to facilitate its removal. Opening 48 is closed.Because the walls of oviduct 12 were never secured against each other,no adhesion of the walls will have occurred and full fertility should bereadily restored.

Although this invention has been described with respect to theembodiments of the apparatus and method of the invention, it should beunderstood that many variations and modifications will now be obvious tothose skilled in the art, and it is preferred, therefore, that the scopeof the invention not be limited by the specific disclosure herein, butonly by the appended claims.

I claim:

1. A device for occluding an oviduct comprising, an occluding memberhaving a base portion of a first width contoured to lodge in the oviductand to be engaged by the walls thereof;

a securing means attached to said occluding member for being secured tosaid oviduct and for holding said occluding member in position;

a narrowed width forward portion narrower than said first width forextending into the oviduct; a forward end of said occluding memberforward of said forward portion; said securing means being positionedand adapted to occlude the oviduct about said forward portion of saidoccluding member.

2. The occluding device of claim 1, wherein said occluding member iscomprised of an inert material.

3. In combination, the occluding device of claim 1 and an insertionelement for inserting said occluding member into the oviduct; saidinsertion element being removably secured to said occluding member andbeing separable therefrom upon compledon of insertion.

4. The combination of claim 3, wherein said insertion element comprisesan elongated rod of sufficient length to extend from the inlet of theoviduct to the location at which said occluding member is to be lodged.

5. The occluding device of claim 1, wherein said occluding member baseportion has a tapering neck leading into said occluding member forwardportion, whereby said occluding member lodges in the oviduct at thejunction between the ampulla and the isthmus.

6. The occluding device of claim 1, wherein said securing meanscomprises a suture secured to said occluding member.

7. In combination, the occluding device of claim 1, and a securing meansguide device removably secured to said occluding member;

said securing means being carried by said guide device into the oviductso as to be positioned thereby for later securement of the securingmeans so as to enable said securing means to occlude the oviduct aboutsaid occluding member forward portion.

8. The combination of claim 7, wherein said guide device is structuredand positioned to carry said securing means forward of said occludingmember forward portion.

9. The combination of claim 8, wherein said guide device comprises ahollow tube which fits over said occluding member forward portion andincludes a forward opening which is forward of said occluding memberforward portion;

said securing means comprising a suture secured to said occludingmember; said suture being passed through said guide device tube, andextending out of said forward opening for being held forward of saidoccluding member forward portion.

10. The combination of claim 9, wherein said guide device forwardopening is defined by a forward end, which is sufficiently rigid andsharp to punch through the wall of the oviduct.

11. The combination of claim 9 and an insertion element for insertingsaid occluding member into the oviduct; said insertion element beingsecurable to said occluding member and being separable therefrom uponcompletion of insertion.

12. A method of occluding an oviduct comprising the steps of:

passing an occluding member into the oviduct through its entrance; and

lodging the occluding member in the oviduct at the narrowing junctionbetween the ampulla and the isthmus of the oviduct and blocking theoviduct with the occluding member.

13. The method of occluding an oviduct of claim 12,

comprising the further step of securing the occluding member in theoviduct where it has lodged.

14. The method of occluding an oviduct of claim 13, wherein before beingpassed into the oviduct, the occluding member is positioned on aninsertion rod;

the occluding member is passed into the oviduct by the rod being passedinto the oviduct;

the insertion rod is separated from the occluding member after theoccluding member has been lodged in the oviduct.

15. The method of occluding an oviduct of claim 13, wherein before beingpassed into the oviduct, the occluding member is provided with asecuring means; and

after the occluding member is lodged in the oviduct,

the securing means is secured to hold the occluding member in theoviduct.

16. The method of occluding an oviduct of claim 15, wherein the securingmeans is a suture;

an opening is made in the wall of the oviduct forward of the locationwhere the occluding member is to be lodged;

after the occluding member is lodged in the oviduct,

the suture is passed through the opening in the wall and is then wrappedabout the oviduct to occlude the oviduct about the occluding member.

17. The method of occluding an oviduct of claim 16, wherein the sutureis passed through a guide device which carries the free end of thesuture forward of the occluding member as the occluding member is passedinto the oviduct;

after the occluding member has been lodged in the oviduct, both theguide device and the suture are drawn through the opening in the oviductwall, the guide device is then removed from the suture, and the sutureis then wrapped about the oviduct to occlude it.

18. The method of occluding an oviduct of claim 17, wherein after theoccluding member has been lodged in the oviduct, the oviduct and guidedevice are manipulated with respect to each other to cause the guidedevice to form the opening in the wall of the oviduct.

19. In combination, the method of occluding an oviduct of claim 15 and amethod of removal of the occluding member;

the method of removal comprising the steps of releasing the securingmeans; and

squeezing the walls of the oviduct against the occluding member to forcethe member to shift out of the oviduct.

1. A device for occluding an oviduct comprising, an occluding memberhaving a base portion of a first width contoured to lodge in the oviductand to be engaged by the walls thereof; a securing means attached tosaid occluding member for being secured to said oviduct and for holdingsaid occluding member in position; a narrowed width forward portionnarrower than said first width for extending into the oviduct; a forwardend of said occluding member forward of said forward portion; saidsecuring means being positioned and adapted to occlude the oviduct aboutsaid forward portion of said occluding member.
 2. The occluding deviceof claim 1, wherein said occluding member is comprised of an inertmaterial.
 3. In combination, the occluding device of claim 1 and aninsertion element for inserting said occluding member into the oviduct;said insertion element being removably secured to said occluding memberand being separable therefrom upon completion of insertion.
 4. Thecombination of claim 3, wherein said insertion element comprises anelongated rod of sufficient length to extend from the inlet of theoviduct to the location at which said occluding member is to be lodged.5. The occluding device of claim 1, wheRein said occluding member baseportion has a tapering neck leading into said occluding member forwardportion, whereby said occluding member lodges in the oviduct at thejunction between the ampulla and the isthmus.
 6. The occluding device ofclaim 1, wherein said securing means comprises a suture secured to saidoccluding member.
 7. In combination, the occluding device of claim 1,and a securing means guide device removably secured to said occludingmember; said securing means being carried by said guide device into theoviduct so as to be positioned thereby for later securement of thesecuring means so as to enable said securing means to occlude theoviduct about said occluding member forward portion.
 8. The combinationof claim 7, wherein said guide device is structured and positioned tocarry said securing means forward of said occluding member forwardportion.
 9. The combination of claim 8, wherein said guide devicecomprises a hollow tube which fits over said occluding member forwardportion and includes a forward opening which is forward of saidoccluding member forward portion; said securing means comprising asuture secured to said occluding member; said suture being passedthrough said guide device tube, and extending out of said forwardopening for being held forward of said occluding member forward portion.10. The combination of claim 9, wherein said guide device forwardopening is defined by a forward end, which is sufficiently rigid andsharp to punch through the wall of the oviduct.
 11. The combination ofclaim 9 and an insertion element for inserting said occluding memberinto the oviduct; said insertion element being securable to saidoccluding member and being separable therefrom upon completion ofinsertion.
 12. A method of occluding an oviduct comprising the steps of:passing an occluding member into the oviduct through its entrance; andlodging the occluding member in the oviduct at the narrowing junctionbetween the ampulla and the isthmus of the oviduct and blocking theoviduct with the occluding member.
 13. The method of occluding anoviduct of claim 12, comprising the further step of securing theoccluding member in the oviduct where it has lodged.
 14. The method ofoccluding an oviduct of claim 13, wherein before being passed into theoviduct, the occluding member is positioned on an insertion rod; theoccluding member is passed into the oviduct by the rod being passed intothe oviduct; the insertion rod is separated from the occluding memberafter the occluding member has been lodged in the oviduct.
 15. Themethod of occluding an oviduct of claim 13, wherein before being passedinto the oviduct, the occluding member is provided with a securingmeans; and after the occluding member is lodged in the oviduct, thesecuring means is secured to hold the occluding member in the oviduct.16. The method of occluding an oviduct of claim 15, wherein the securingmeans is a suture; an opening is made in the wall of the oviduct forwardof the location where the occluding member is to be lodged; after theoccluding member is lodged in the oviduct, the suture is passed throughthe opening in the wall and is then wrapped about the oviduct to occludethe oviduct about the occluding member.
 17. The method of occluding anoviduct of claim 16, wherein the suture is passed through a guide devicewhich carries the free end of the suture forward of the occluding memberas the occluding member is passed into the oviduct; after the occludingmember has been lodged in the oviduct, both the guide device and thesuture are drawn through the opening in the oviduct wall, the guidedevice is then removed from the suture, and the suture is then wrappedabout the oviduct to occlude it.
 18. The method of occluding an oviductof claim 17, wherein after the occluding member has been lodged in theoviduct, the oviduct and guide device are manipulated with respect toeach other to cause the guide device to form the opening in the wall ofthe oviduct.
 19. In combination, the method of occluding an oviduct ofclaim 15 and a method of removal of the occluding member; the method ofremoval comprising the steps of releasing the securing means; andsqueezing the walls of the oviduct against the occluding member to forcethe member to shift out of the oviduct.